9 results
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17ms
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Sources: EU EUDAMED, US FDA
SERUM COMPLEMENT ACTIVITY TEST-SCAT
FDA 510(k)
FDA Class 2
·Immunology
COMPEL MLR SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XIDF-AWS801, ANGIO WORKSTATION, V5.31
FDA 510(k)
FDA Class 2
·Radiology
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 22, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 30, 2014
EXPRESS BILIARY SD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·September 22, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024